1st Edition
Basics of Pharmaceutical Manufacturing and Quality Operations A Comprehensive Guide
Preface
Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)
Chapter 2 Concept of Calibration
Chapter 3 Reference Standards and Reagents
Chapter 4 Chemical Tests
Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products
Chapter 6 Data Integrity
Chapter 7 Process Validation
Chapter 7.1 Protocol Generation
Chapter 7.2 Sampling and Testing Plan
Chapter 7.3 Process Validation Report Writing
Chapter 8 Cleaning Validation
Chapter 9 Method Development and Method Validation
Chapter 10 Qualification and Its Segments
Chapter 10.1 User Requirement Specification
Chapter 10.2 Functional Specification
Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates
Chapter 12 Technology Transfer
Chapter 13 Dispensing
Chapter 14 Production
Chapter 15 Packaging
Chapter 16 Role of Quality Assurance
Chapter 17 Role of Quality Control
Chapter 18 Logistics – Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines
Chapter 20 QA/QC Release
Index
Biography
Erfan Syed Asif earned his PhD in organic chemistry and has expertise in various areas of quality operations with over 28 years of experience in pharmaceutical industries in Pakistan, UAE, Kingdom of Saudi Arabia, United States, and Canada. He has worked in U.S. FDA‑ and Health Canada‑approved facilities in various Leading roles. He has extensive experience in overseeing qualification projects for manufacturing equipment, utilities, systems, sterilization techniques, aseptic processes simulation, API site audits and sterile and non‑sterile products manufacturing processes, and decommissioning of equipment.
Usmani Shahid Bader obtained his Ph.D. in organic chemistry and has expertise in various areas of quality operations with over 25 years of experience in pharmaceutical industries in Pakistan and Canada. He has worked in a leading role in U.S. FDA‑ and Health Canada‑approved facilities. He has extensive experience in overseeing quality projects.
